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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically characterized by a focus on the practical aspects of the study design, such as recruitment and consent as well as adherence to the use of standard equipment.

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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and included participants from different geographical regions. This type of heterogeneity is required for practical trials to be valid and helps reduce the chance of bias in the results. However, too much heterogeneity can result in problems with the trial design.

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The aim of pragmatic trials is to mimic real-life scenarios and gain maximum validity externally. They are usually requested by practitioners and policy makers to guide their decision-making. They can also be used to assess the causality of an intervention and its effects. However, they should not be used to substitute for explanation trials.

The pragmatism concept is controversial and there are concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested an distinction between explanation-based studies, which support a physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in policy and practice decision-making. They also suggested a framework for pragmatic trials, called PRECIS.2 This tool attempted to define the characteristics of a pragmatic trial, including the recruitment process, the design and delivery of the intervention, as well as the follow-up.

The number of pragmatic trials is growing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) produced 34 articles, as shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatism. However, it is important to remember that the majority of these trials were conducted in primary care settings.